DM Full Guideline (2010) - VA/DoD Clinical Practice Guidelines Home

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Version 4.0 VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus performed by others that described explicit criteria for deciding what evidence was selected and how it was determined to be valid. The sources that have already undergone rigorous critical appraisal include Cochrane Reviews, Best Evidence, Technology Assessment, and EPC reports. The search continued using well-known and widely available databases that were appropriate for the clinical subject. In addition to Medline/PubMed, the following databases were searched: Database of Abstracts of Reviews of Effectiveness (DARE) and Cochrane Central Register of Controlled Trials (CCTR). For Medline/PubMed, limits were set for language (English), date of publication (2002 through May 2009) and type of research (RCT and metaanalysis). For the CCTR, limits were set for date of publication (2002 through 2009). Once definitive reviews or clinical studies that provided valid relevant answers to the question were identified, the search ended. The search was extended to studies/reports of lower quality (observational studies) only if there were no high quality studies. Exclusion criteria included reviews that omitted clinical course or treatment. Some retrieved studies were rejected on the basis of published abstracts, and a few were rejected after the researchers scanned the retrieved citation for inclusion criteria. Typical exclusions included studies with physiological endpoints or studies of populations that were not comparable to the population of interest (e.g., studies of diabetes in children or pregnancy). The results of the search were organized and reported using reference manager software. At this point, additional exclusion criteria were applied. The bibliographies of the retrieved articles were hand-searched for articles that may have been missed by the computer search. Additional experts were consulted for articles that may also have been missed. The literature search for the guideline update was validated by: (1) comparing the results to a search conducted by the independent research and appraisal team; (2) a review of the database by the expert panel; and (3) requesting articles pertaining to special topics from the experts in the working group. Preparation of Evidence Tables The results of the searches were organized in evidence reports, and copies of the original studies were provided to the WG for further analysis. Each reference was appraised for scientific merit, clinical relevance, and applicability to the populations served by the VA and DoD healthcare systems. The clinical experts and other researchers in healthcare independently read and coded each article that met inclusion criteria. Each article was turned into a one-page summary of the critical appraisal by the research team and added to a central electronic database.. Each of the evidence reports covered: • Summary of findings • Methodology • Search terms • Resources searched • Summary table of findings • Critical appraisal of each study The quality rating procedure used in this update was different from the rating scale used in the development of the original guideline in 1999. Where adjustments to the update process were made, articles from the original process were re-graded to reflect the changed rating scale (e.g., the strength of recommendation [SR] was assigned for each recommendation, based on study design and significance of the quality of the evidence). Evidence-based practice involves integrating clinical expertise with the best available clinical evidence derived from systematic research. The Working Group reviewed the evidence and graded it using the rating scheme developed by the USPSTF (2007). The experts themselves, after an orientation and tutorial on the evidence grading process, formulated Quality of Evidence ratings (see Table 1), a rating of Overall Quality (see Table 2), a rating of the Net Effect of the Intervention (see Table 3), and an overall Recommendation (see Table 4). Appendices Page 123
Version 4.0 I II-1 II-2 II-3 III Good Fair Poor Substantial Moderate Small Zero or Negative TABLE 1: Quality of Evidence (QE) At least one properly done RCT Well designed controlled trial without randomization Well designed cohort or case-control analytic study Multiple time series, dramatic results of uncontrolled experiment Opinion of respected authorities, case reports, and expert committees TABLE 2: Overall Quality High grade evidence (I or II-1) directly linked to health outcome High grade evidence (I or II-1) linked to intermediate outcome; or Moderate grade evidence (II-2 or II-3) directly linked to health outcome Level III evidence or no linkage of evidence to health outcome VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus TABLE 3: Net Effect of the Intervention More than a small relative impact on a frequent condition with a substantial burden of suffering; or A large impact on an infrequent condition with a significant impact on the individual patient level. A small relative impact on a frequent condition with a substantial burden of suffering; or A moderate impact on an infrequent condition with a significant impact on the individual patient level. A negligible relative impact on a frequent condition with a substantial burden of suffering; or A small impact on an infrequent condition with a significant impact on the individual patient level. Negative impact on patients; or No relative impact on either a frequent condition with a substantial burden of suffering; or An infrequent condition with a significant impact on the individual patient level. TABLE 4: Final Grade of Recommendation The net benefit of the intervention Quality of Evidence Substantial Moderate Small Zero or Negative Good A B C D Fair B B C D Poor I I I I A B C D I A strong recommendation that the intervention is always indicated and acceptable A recommendation that the intervention may be useful/effective A recommendation that the intervention may be considered A recommendation that a procedure may be considered not useful/effective, or may be harmful. Insufficient evidence to recommend for or against – the clinician will use clinical judgment Lack of Evidence – Consensus of Experts The majority of the literature supporting the science for these guidelines is referenced throughout the document and is based upon key RCTs and longitudinal studies published from 2002 through May 2009. Following the independent review of the evidence, a consensus meeting was held to discuss discrepancies in ratings and formulate recommendations. Where existing literature was ambiguous or conflicting, or where scientific data was lacking on an issue, recommendations were based on the clinical experience of the Working Group. These recommendations are indicated in the evidence tables as based on “Working Group Consensus”. Appendices Page 124
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